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Analgesics & Antipyretics

Arastad 20

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains leflunomide 20 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30°C.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Used as a disease-modifying antirheumatic drug in the treatment of active rheumatoid arthritis in adults.
  • Also used in the treatment of active psoriatic arthritis.
     
  • Arastad 20 is administered orally without regard to meals.
  • Because of the long half-life of the principal metabolite, a loading dose of leflunomide is required to reach steady-state concentrations relatively rapidly. Therapy should start with an oral loading dose of 100 mg once daily for 3 days. However, in practice, the loading dose may be omitted in those patients at an increased risk of adverse effects, particularly haematological or hepatic effects.
    The maintenance dose:
    Rheumatoid arthritis: 10 - 20 mg once daily.
    Psoriatic arthritis: 20 mg once daily.
    Dose adjustments may be necessary in patients who develop abnormal liver enzyme values. The therapeutic effect usually starts after 4 to 6 weeks of therapy and further improvements may occur for up to 6 months.
    Patients with hepatic impairment:
    Patients who develop moderate elevations of liver enzyme values (defined as transaminase levels 2 to 3 times the normal upper limit) while receiving leflunomide treatment should have their dose reduced to 10 mg daily; if necessary, monitoring of liver enzyme values should also be performed at weekly intervals. If moderate elevations persist or if severe elevations occur, leflunomide should be stopped and washout procedure.
    Paediatric:
    Safety and efficacy of leflunomide in children and adolescents younger than 18 years of age have not been established.
    Geriatric:
    The routine dosage adjustment is not necessary in geriatric patients older than 65 years of age.
     

Or as prescribed by physicians.

 

  • Patients with hepatic impairment.
  • Women who are or may become pregnant.
  • Patients with known hypersensitivity to leflunomide or to any ingredient of the drug.

     

Common:

  • Hypertension, gastrointestinal disturbances (particularly diarrhoea), weight loss, headache, dizziness, nausea, vomiting, mouth ulcer, leucopenia, asthenia, paraesthesia, joint disorders and synovitis, upper respiratory-tract infections, alopecia, eczema, and dry skin.
  • Hypersensitivity reactions may occur.
  • A few cases of Stevens-Johnson syndrome, erythema multiform, toxic epidermal necrolysis, or vasculitis have been reported.
  • Hepatotoxicity has occurred. It is usually mild and reversible but rare cases of severe, sometimes fatal, liver disease, including acute hepatic necrosis, have been seen particularly in the first 6 months of therapy.

Others:

  • Anxiety, peripheral neuropathy, hypokalaemia, and mild hyperlipidaemia.
  • Pancytopenia, agranulocytosis, and thrombocytopenia; these effects are more common when leflunomide is given with other myelosuppressive drugs.
  • Pancreatitis, interstitial lung disease, and severe infections, including fatal sepsis.
  • Renal failure has also been reported.

     

  • Immunosuppression potential/ bone marrow suppression:
    Leflunomide is not recommended for patients with severe immunodeficiency, bone marrow dysplasia, or severe, uncontrolled infections. Pancytopenia, agranulocytosis and thrombocytopenia have been reported most frequently in patients who received concomitant treatment with methotrexate or other immunosuppressive agents, or who had recently discontinued these therapies; in some cases, patients had a prior history of a significant hematologic abnormality. Patients taking leflunomide should have platelet, white blood cell count and hemoglobin or hematocrit monitored at baseline and monthly for six months following initiation of therapy and every 6 to 8 weeks thereafter. If used with concomitant methotrexate and/or other potential immunosuppressive agents, chronic monitoring should be monthly. If evidence of bone marrow suppression occurs in a patient taking leflunomide, treatment with leflunomide should be stopped, and cholestyramine or charcoal should be used to reduce the plasma concentration of leflunomide active metabolites.
  • Hepatotoxicity:
    Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide. Most cases of severe liver injury occur within 6 months of therapy and in a setting of multiple risk factors for hepatotoxicity.
  • Pre-existing hepatic disease:
    Given the possible risk of increased hepatotoxicity, and the role of the liver in drug activation, elimination and recycling, the use of leflunomide is not recommended in patients with significant hepatic impairment or evidence of infection with hepatitis B or C viruses.
  • Skin reactions:
    Rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported in patients receiving leflunomide. If a patient taking leflunomide develops any of these conditions, leflunomide therapy should be stopped, and a drug elimination procedure is recommended.
  • Malignancy:
    The risk of malignancy, particularly lymphoproliferative disorders, is increased with the use of some immunosuppression medications.
  • Prolonged leflunomide exposure following discontinuance:
    Because it can take up to 2 years for plasma concentrations of the active metabolite of leflunomide (A77 1726) to decrease to undetectable concentrations (less than 0.02 mcg/ml) following discontinuance of leflunomide, the possibility that adverse effects or drug interactions associated with the drug could continue to occur even though the patient is no longer receiving leflunomide should be considered. When more rapid elimination of A77 1726 is indicated or desirable, including following discontinuance of leflunomide in women of childbearing potential or in patients with potentially serious drug-related adverse effects (e.g., persistently increased liver function test results, severe dermatologic or sensitivity reactions, bone marrow suppression, pancytopenia) the manufacturer recommends use of a drug elimination procedure. A drug elimination procedure also may be appropriate in patients who are discontinuing leflunomide therapy and will receive subsequent therapy with a drug with a known potential for hematologic suppression.
  • Interstitial lung disease is a potentially fatal disorder, which may occur acutely at any time during therapy with leflunomide.
  • Leflunomide should be used with caution in patients with renal impairment since the drug has not been evaluated clinically in this population and the kidneys play a role in elimination of the drug.
     
  • Pregnancy: There are no adequate and well-controlled studies evaluating leflunomide in pregnant women. However, based on animal studies, leflunomide may increase the risk of fetal death or teratogenic effects when administered to pregnant women. Women of childbearing potential must not be started on leflunomide until pregnancy is excluded and it has been confirmed that they are using reliable contraception. Before starting treatment with leflunomide, patients must be fully counseled on the potential for serious risk to the fetus. Pregnancy must be avoided during leflunomide treatment or prior to the completion of the drug elimination procedure after leflunomide treatment.
  • Lactation: It is not known whether leflunomide is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to proceed with nursing or to initiate treatment with leflunomide, taking into account the importance of the drug to the mother.
     
  • In the case of side effects such as dizziness the patient's ability to concentrate and to react properly may be impaired. In such cases patients should refrain from driving and using machines.

     

Contact us

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